Isiris™ a ALFA01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05707480136063), received between Feb 1, 2023 and Aug 14, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING PROCEDURE, THE OPERATOR WANTED TO GRASP THE JJ CATHETER AFTER THE ISIRIS ALFA WAS INTRODUCTION INTO THE BLADDER. THE CLAW OF THE GRASPER DETACHED. A SECOND ENDOSCOPE WAS THEN USED TO RETRIVE THE DETACHED CLAW FROM THE BLADDER CAVITY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17539347 ↗
• MalfunctionFeb 17, 2023Mechanical Problem; Mechanical Problem

  DURING PROCEDURE THE LOWER PART OF THE CYSTOSCOPE'S GRASPER FBROKE AND DISLODGED INTO THE PATIENT'S BLADDER. GRASPER WAS REMOVED USING ANOTHER CYSTOSCOPE. PATIENT OUTCOME NOT AFFECTED..

  Patient problems: Foreign Body In Patient

  MAUDE report 16395745 ↗
• MalfunctionFeb 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN ATTEMPT TO REMOVE A STENT WITH AN ISIRIS CYSTOSCOPE, THE OPERATOR HAD DIFFICULTIES TO REMOVE THE STENT, THE GRASPER OF THE SCOPE, AND DISLODGE TO PATIENT'S BLADDER. A FLEXIBLE CYSTOSCOPE WAS USED TO RETRIEVE THE GRASPER IN THE BLADDER CAVITY AND TO REMOVE THE STENT. THE PROCEDURE WAS PROLONGED WITH 30 MINUTES. NO HARM TO PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16276635 ↗